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A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell’s palsy: the BELLS study

By F.M. Sullivan, I.R.C Swan, P.T. Donnan, J.M. Morrison, Blair Hamilton Smith, B McKinstry, R.J. Davenport, Luke David Vale, J.E. Clarkson, Rodolfo Andrés Hernández, K Stewart, V Hammersley, S Hayavi, Anne McAteer, Denise Ann Gray and F Daley

Abstract

Objective: To determine whether oral prednisolone or aciclovir, used separately or in combination, early in the course of Bell’s palsy, improves the chances of recovery at 3 and 9 months. Design: A 2 × 2 factorial randomised double-blind trial. Patients were randomly assigned to treatment by an automated telephone service using a permuted block randomisation technique with block sizes of four or eight, and no stratification. Setting: Mainland Scotland, with referrals mainly from general practice to 17 hospital trial sites. Participants: Adults (aged 16 years or older) with unilateral facial nerve weakness of no identifiable cause presenting to primary care, the emergency department or NHS24 within 72 hours of symptom onset. Interventions: Patients were randomised to receive active preparations or placebo for 10 days: (1) prednisolone (50 mg per day, 2 × 25-mg capsules) and aciclovir (2000 mg per day, 5 × 400-mg capsules); (2) prednisolone and placebo (lactose, indistinguishable); (3) aciclovir and placebo; and (4) placebo and placebo. Outcome measures: The primary outcome was recovery of facial function assessed by the House– Brackmann scale. Secondary outcomes included health status, pain, self-perceived appearance and costeffectivenes Results: Final outcomes were available for 496 patients, balanced for gender; mean age 44 years; initial facial paralysis moderate to severe. One half of patients initiated treatment within 24 hours of onset of symptoms, one-third within 24–48 hours and the remainder within 48–72 hours. Of the completed patients, 357 had recovered by 3 months and 80 at 9 months, leaving 59 with a residual deficit. There were significant differences in complete recovery at 3 months between the prednisolone comparison groups\ud (83.0% for prednisolone, 63.6% for no prednisolone, a difference of + 19.4%; 95% confidence interval (CI): + 11.7% to + 27.1%, p < 0.001). The number needed to treat (NNT) in order to achieve one additional complete recovery was 6 (95% CI: 4 to 9). There was no significant difference between the acyclovir comparison groups (71.2% for aciclovir and 75.7% for no aciclovir). Nine-month assessments of patients recovered were 94.4% for prednisolone compared with 81.6% for no prednisolone, a difference of + 12.8% (95% CI: + 7.2% to + 18.4%, p < 0.001); the NNT was 8 (95% CI: 6 to 14). Proportions recovered at 9 months were 85.4% for aciclovir and 90.8% for no aciclovir, a difference of – 5.3%. There was no significant prednisolone–aciclovir interaction at 3 months or at 9 months. Outcome differences by individual treatment (the four-arm model) showed significant differences. At 3 months the recovery rate was 86.3% in the prednisolone treatment group, 79.7% in the aciclovir– prednisolone group, 64.7% in the placebo group and 62.5% in the aciclovir group. At 9 months the recovery rates were respectively 96.1%, 92.7%, 85.3% and 78.1%. The increase in recovery rate conferred by the addition of prednisolone (both for prednisolone over placebo and for aciclovir–prednisolone over aciclovir) is highly statistically significant (p < 0.001). There were no significant differences in secondary measures apart from Health Utilities Index Mark 3 (HUI3) at 9 months in those treated with prednisolone. Conclusions: This study provided robust evidence to support the early use of oral prednisolone in Bell’s palsy as an effective treatment which may be considered costeffective. Treatment with aciclovir, either alone or with steroids, had no effect on outcome. Trial registration: Current Controlled Trials ISRCTN71548196.The Chief Scientist Office of the Scottish Government Health Directorates. The University of Dundee.Peer reviewedPublisher PD

Topics: Anti-inflammatory Agents, Antiviral Agents, Bells Palsy, RC Internal medicine
Publisher: Gray Publications
Year: 2009
DOI identifier: 10.3310/hta13470
OAI identifier: oai:aura.abdn.ac.uk:2164/291
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    1. acute.and.transient.facial.paralysis..Ann Otol Rhinol Laryngol.1995;104:574–81.
    2. paralysis).(Cochrane.Review)..In:.The Cochrane Library,.Issue.2,.2002..Oxford:.Update.Software. doi
    3. AR,.Moher.M,.et al..Does.quality.of.reports.of. randomised.trials.affect.estimates.of.intervention. doi
    4. (1996). controlled.trial..Ann Otol Rhinol Laryngol.
    5. WC,.Grimshaw.J,.et al..The.Chronic.Pain.Grade. doi
    6. Information.and.Statistics.Division..ISD Scotland Guide: an
    7. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 67 A.Trial.Steering.Committee.(TSC).should.be.set.up.with.the.following.terms.of.reference: Terms of reference 1..
    8. (2009). Data Monitoring and Ethics Committee Professor.Marion.Campbell,.University.of. Aberdeen Dr.Carl.Counsell,.University.of.Aberdeen Mr.Rodney.Mountain,.University.of.Dundee Dr.Simon.Ogston.(Statistician),.University.of. Dundee DOI:
    9. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 77 Scottish.Bell’s.Palsy.Study.The.‘BELLS’.study HTA.02/09/04 The.application.to.HTA.was.naturally.preceded.by.
    10. Local ethical approvals Our.applications.for.local.ethics.approvals.
    11. Local R&D approvals doi
    12. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 81 Appendix 6 How cruel to call it Bell’s palsy by Graeme Garden On.December.1st.2002,.while.driving.south.along.the.M6,.I.discovered.that.I.couldn’t.
    13. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 85 What is Bell’s palsy and how is it treated?
    14. please let us know very soon if you are happy to join the study so that treatment can commence. Preferably, tell the doctor that gave you this information sheet now. Will there be side effects?
    15. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 87 Appendix 9 Form A Appendix 9 88 Scottish Bell’s Palsy Study ‘BELLS’ Patient case record form Form A v.8 dated 19th
    16. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 91 Appendix 10 Consent form Appendix 10 92 Scottish Bell’s Palsy Study Consent Form v.6 dated 18th
    17. (2009). Queen’s Printer and Controller of HMSO. All rights reserved.
    18. The number of the Randomisation Service is 1611 111111.. Before you begin you will need your npw*(p w+vmp( which is
    19. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 97 Appendix 12 Recruiters’ notes
    20. (2009). After all visits send letters to GP and patient, keep copies despatch original completed questionnaires to TCGP, keep copies email photographs to TCGP DOI: 10.3310/hta13470 Health Technology Assessment
    21. (2009). d ur in g th e la st 2 4 ho ur s.
    22. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 125 For questions 1 to 33 use the scale
    23. This.patient.never.commenced.BELLS.medications Patient reference 2617009 Date.of.Consent.to.BELLS.study.
    24. (1999). Assessment reports published to date 132
    25. (2003). Health Technology Assessment reports published to date 136
    26. (2006). Health Technology Assessment reports published to date 142
    27. (2007). Health Technology Assessment reports published to date 144
    28. (2008). Assessment reports published to date 146
    29. (2009). Health Technology Assessment reports published to date
    30. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 151 Health Technology Assessment programme
    31. AR,.Moher.M,.et al..Does.quality.of.reports.of. doi
    32. Utilities.Index..Pharmacoeconomics 1995;7:490–502. 25.. Information.and.Statistics.Division..ISD Scotland Guide: an doi
    33. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 67 A. Trial.Steering.Committee.(TSC).should.be.set. up.with.the.following.terms.of.reference: Terms of reference 1..
    34. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 87 Appendix 9 Form AAppendix 9 88 Scottish Bell’s Palsy Study ‘BELLS’ Patient case record form Form A v.8 dated 19th
    35. (2009). Patient number (allocated by doi
    36. (2009). advise the BELLS Coordinator IMMEDIATELY that a new patient has been recruited, and provide the patient’s name, address and telephone number: f.daly@tcgp.dundee.ac.uk 01382 000000 (W) / 01738 000000 (H) / 0771 000 0000 (M) DOI:
    37. (2009). After all visits send letters to GP and patient, keep copies despatch original completed questionnaires to TCGP, keep copies email photographs to TCGP DOI:
    38. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 121 F o r Q u e s t i o n s 6 t o 1 2 c i r c l e o n e n u m b e r o n l y t h a t d e s c r i b e s h o w
    39. (2009). 52 How confident do you feel?
    40. (2001). Assessment reports published to date 134
    41. (2009). Reilly.C,.et al.DOI: 10.3310/hta13470 Health Technology Assessment
    42. (2003). Woolacott.N,.Forbes.C,.Shirran.L,.et al.Health Technology Assessment reports published to date 136
    43. (2009). Crabbe.D,.Pearce.R,.Bhandari.P,.et al.DOI: 10.3310/hta13470 Health Technology Assessment
    44. (2004). Assessment reports published to date 138 doi
    45. (2005). Assessment reports published to date 140
    46. (2006). Thomas.S,.Lamb.J,.Bain.L,.et al.Health Technology Assessment reports published to date 142
    47. (2009). Iglesias.CP,.Hawkins.K,.Cullum.NA,.et al.DOI: 10.3310/hta13470 Health Technology Assessment
    48. (2007). Cafferty.F,.Demiris.N,.Dyer.M,.et al.Health Technology Assessment reports published to date 144
    49. (2009). al.DOI: 10.3310/hta13470 Health Technology Assessment
    50. (2008). Knight.R,.et al.Health Technology Assessment reports published to date 146
    51. (2009). Hartwell.D,.et al.DOI: 10.3310/hta13470 Health Technology Assessment
    52. (2009). Queen’s Printer and Controller of HMSO. All rights reserved. 153 Therapeutic.Procedures.Panel Members Chair, Dr

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